HIFU Atrial Fibrillation Treatment

High Intensity Focused Ultrasound (HIFU) is a technique which uses focused ultrasound energy to selectively destroy biological tissue at depth (typically 1 to 10 cm) without affecting intervening, anatomical structures. Spectrasonics' objective is the development and commercialization of ultrasonically-guided HIFU therapy systems for use in the non-invasive treatment of diseases of the heart, breast, uterus, prostate and abdominal organs such as the liver, kidney and pancreas.

As an initial HIFU application Spectrasonics has identified cardiac ablation for the treatment of atrial fibrillation. The standard treatment for atrial fibrillation involves using either a scalpel or an RF cauterizer to destroy strips of heart tissue in the left atrium and/or region surrounding the pulmonary veins. This procedure is performed primarily during cardiac bypass operations and works by blocking the degenerate electrophysiological pathways that cause fibrillation. The surgical approach is significantly invasive and the RF approach, while leaving the structure of the heart tissue intact, is not focused and therefore requires the destruction of a relatively wide band (>1cm) of tissue in order to ensure full penetration through the heart wall. We have demonstrated the ability to produce sharply focused (1mm wide), transmural (1cm deep) cardiac lesions with HIFU in vitro and believe that this approach can greatly reduce the tissue damage and risk involved in atrial ablation procedures. Ultimately we believe the procedure will be performed thoroscopically. This would mean that it could be applied to patients not requiring open chest surgery. A series of successful in vivo, proof-of-concept tests have been completed and a first generation device will be ready for clinical testing in the 4th quarter of 2002.


The Market

Atrial fibrillation afflicts more than 2 million Americans and has an annual incidence of 160,000 cases. Direct costs are greater than $4 billion annually. Indirect costs of $40 billion are associated with treating AF patients who have had a consequential stroke. In 14% of the 600,000 cardiac bypass operations performed each year and 50% of the 71,000 mitral valve replacement procedures, the patient suffers from chronic atrial fibrillation. This indicates an initial market of at least 119,000 patients per year for our cardiac ultrasound therapy technique.


© 2004 Spectrasonics, Inc.

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